Measuring cerebral oxygen saturation

ABSTRACT

A device includes source and detector sensors. In a specific implementation, the device has two near detectors, two far detectors, and two sources. The two near detectors are arranged closer to the two sources than the two far detectors. A light-diffusing layer covers the two near detectors. The device may be part of a medical device that is used to monitor or measure oxygen saturation levels in a tissue. In a specific implementation, light is transmitted into the tissue and received by the detectors. An attenuation coefficient is first calculated for a shallow layer of tissue. The attenuation coefficient is then used to calculate an attenuation coefficient for a deep layer of tissue.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation-in-part of U.S. design patentapplication Ser. No. 29/281,301, filed Jun. 20, 2007, issued as U.S.design Pat. No. D568,479 on May 6, 2008, and Ser. No. 29/305,102, filedMar. 13, 2008, which are incorporated by reference along with all otherreferences cited in this application.

BACKGROUND OF THE INVENTION

The present invention relates to medical devices and their manufacture.More particularly, the present invention relates to patient monitoringdevices and methods.

Patient monitoring systems measure, display, and sometimes storephysiological data. Patient monitoring systems are now used in a widevariety of applications. This includes, for example, hospital,ambulatory, and home health care. Hospitals routinely measure andanalyze the vital signs of surgical, trauma, and other patients fromadmission through discharge. There are many different types ofmonitoring devices. For example, there are monitoring devices for bloodpressure, body temperature, heart activity, blood gases, cholesterol,glucose, pulse rate, respiration rate, tissue oxygen saturation, andmany other parameters.

Noninvasive monitoring devices fulfill an important role in assessing,tracking, diagnosing, and treating patients. These devices enable earlydiagnosis, treatment of acute conditions, and reduce the need forinvasive interventions. Some types of monitoring devices gather patientdata via sensors attached to the patient.

Near-infrared spectroscopy has been used for noninvasive measurement ofvarious physiological properties in animal and human subjects. The basicprinciple underlying the near-infrared spectroscopy is thatphysiological tissues include various highly-scattering chromophores tothe near-infrared waves with relatively low absorption. Many substancesin a medium may interact or interfere with the near-infrared light wavespropagating therethrough. Human tissues, for example, include numerouschromophores such as oxygenated hemoglobin, deoxygenated hemoglobin,water, lipid, and cytochrome, where the hemoglobins are the dominantchromophores in the spectrum range of approximately 700 nanometers toapproximately 900 nanometers. Accordingly, the near-infraredspectroscope has been applied to measure oxygen levels in thephysiological medium such as tissue hemoglobin oxygen saturation andtotal hemoglobin concentrations.

There is, then, a continuing demand for medical devices that are moresensitive, easier to use, safer to use, provide more features, andgenerally address the needs of patients, doctors, and others in themedical community. For example, current near-infrared devices havedifficulty detecting various properties of deep layer tissue, such asthe brain.

Therefore, there is a need to provide improved systems and techniquesfor monitoring patients.

BRIEF SUMMARY OF THE INVENTION

The present invention relates to patient monitoring devices. In anembodiment, the invention uses cerebral tissue oxygen saturationmeasurements to assess oxygen supply and blood circulation in the brainfor the purpose of guiding cardiac surgeries or other types of surgeriesthat may affect oxygen supply and blood circulation in the brain.Cerebral tissue oxygen saturation measurement may be determined bycombining a two-layer model and an automatic error cancellation scheme.The invention may obtain a tissue oxygen saturation measurement of atissue layer that is covered by another layer of tissue.

In an embodiment, the invention is a device including a first sourcestructure, a first near detector structure, a first far detectorstructure, and a light diffusing layer, where the first near detectorstructure receives a beam of light after the beam of light has beentransmitted through a tissue and the light diffusing layer. The firstsource structure, first near detector structure, and first far detectorstructure may be arranged in a line.

A first distance between the first source structure and the first neardetector structure may be different from a second distance between thefirst source structure and first far detector structure. The firstdistance may be less than the second distance. The first distance may beapproximately 30 millimeters. The second distance may be approximately40 millimeters.

The device may further include a second source structure, a second neardetector structure, and a second far detector structure, where thesecond near detector structure receives the beam of light after the beamof light has been transmitted through the tissue and the light diffusinglayer. The second source structure, second near detector structure, andsecond far detector structure may be arranged in a line.

A third distance between the second source structure and the second neardetector structure may be different from a fourth distance between thesecond source structure and second far detector structure. The thirddistance may be less than the fourth distance. The third distance may beapproximately 30 millimeters. The fourth distance may be approximately40 millimeters.

In an embodiment, the light diffusing layer may be a semitranslucentfilm. In an embodiment, the first near detector structure, the secondnear detector structure, the first far detector structure, and thesecond far detector structure may comprise photodiodes. The first sourcestructure and second source structure may comprise optical fiber.

In an embodiment, the invention is a method including positioning asensor head to face toward a tissue, where the sensor head comprises afirst source structure, a second source structure, a far detectorarrangement, a near detector arrangement, and a semitranslucent filmcovering the near detector arrangement. Transmitting light through thefirst source structure and the second source structure into a tissue.Receiving light transmitted through the tissue and the detectorarrangement, the received light including attenuation characteristics,and processing the received light using a system unit.

The light may be transmitted from the system unit. Receiving the lighttransmitted through the tissue may be through photodetectors at thesensor head. The attenuation characteristics may be at least partiallycaused by the semitranslucent film.

In an embodiment, the invention is a probe, the probe being adapted foruse as a part of a medical device system for measuring oxygen levels ina tissue. The probe includes a sensor pad having a first cavity, asecond cavity, and a third cavity, where a semitranslucent film iscoupled to a bottom surface of the sensor pad and partially overlaps thefirst cavity. The probe further includes a sensor arrangement whichincludes a plurality photodetectors coupled to the first cavity, a firstsource structure coupled to the second cavity, and a second sourcestructure coupled to the third cavity.

In an embodiment, the invention is a method including placing a sensorhead on a surface of a tissue to be measured and transmitting lightthrough a plurality of sources of the sensor head into the tissue. Themethod further includes receiving light transmitted through the tissueat a first set of detectors and at a second set of detectors, where thereceived light has a first attenuated amount at the first set ofdetectors and a second attenuated amount at the second set of detectors.The method further includes using the first attenuated amount, tocalculate a first attenuation coefficient for a shallow tissue regionhaving a depth of at most about X below the surface of the tissue andusing the second attenuated amount and the first attenuation coefficientcalculate a second attenuation coefficient for a deep tissue regionhaving a depth of at least about Y below the surface of the tissue.

In the method above, in a specific embodiment, X is the same as Y, or Xis less than Y. In various different embodiments, however, X is the sameas Y, X is different from Y, X is less than Y, or X is greater than Y,and any combination of these.

In a specific embodiment, X and Y are about 12 millimeters. Depending onthe person (e.g., adult, child, male, female, human, or animal), X and Ymay range from about 6 millimeters to 20 millimeters, from about 6millimeters to 40 millimeters, and any number in these ranges (e.g., 8,10, 11, 13, 14, 15, 16, 17, 18, 19, 20, 25, 35, 36, or 38) between. Thetissue may include a human scalp, skull, and brain. The secondattenuated amount may be omitted when calculating the first attenuationcoefficient. Calculating the second attenuation coefficient may beperformed after calculating the first attenuation coefficient. Thesecond attenuated amount may be greater than the first attenuatedamount.

A near distance from the set of sources to the first set of detectorsmay be less than a far distance from the set of sources to the secondset of detectors.

In an embodiment the plurality of sources includes a first sourcestructure and a second source structure, and the first plurality ofdetectors includes a first detector structure and a second detectorstructure. The first source structure, second source structure, firstdetector structure, and second detector structure are arranged to definevertices of a quadrilateral. A first side of the quadrilateral betweenthe first source structure and first detector structure is same inlength from a second side of the quadrilateral between the second sourcestructure and the second detector structure. In a specificimplementation, the quadrilateral is convex.

In an embodiment the plurality of sources includes a first sourcestructure and a second source structure, and the first plurality ofdetectors includes a first detector structure and a second detectorstructure. The first source structure, second source structure, firstdetector structure, and second detector structure are arranged to definevertices of a quadrilateral. A first side of the quadrilateral betweenthe first source structure and first detector structure is different inlength from a second side of the quadrilateral between the second sourcestructure and the second detector structure. In a specificimplementation, the quadrilateral is convex.

Other objects, features, and advantages of the present invention willbecome apparent upon consideration of the following detailed descriptionand the accompanying drawings, in which like reference designationsrepresent like features throughout the figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an oximeter system for measuring oxygen saturation of bloodin a patient.

FIG. 2 shows in greater detail, a block diagram of a specificimplementation of the system in FIG. 1.

FIG. 3 shows an optical imaging system in accordance with an embodimentof the present invention.

FIG. 4 shows the wireless transfer of patient data from a field locationto a receiving location.

FIG. 5 shows a perspective view of a sensor.

FIG. 6 shows a top view of the sensor.

FIG. 7a shows a bottom view of an implementation of a symmetricalsensor.

FIG. 7b shows a bottom view of an implementation of an asymmetricalsensor.

FIG. 8 shows a front view of the sensor.

FIG. 9 shows a side view of the sensor.

FIG. 10 shows a cross-sectional view of the sensor.

FIG. 11a shows the sensor placed on a right side of a patient'sforehead.

FIG. 11b shows the sensor placed on a left side of a patient's forehead.

FIG. 11c shows two sensors simultaneously placed on the right and leftsides of a patient's forehead.

FIG. 12 shows a process flow for using the system.

FIG. 13 shows a schematic diagram of the sensor in use.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows an oximeter system 101 for measuring oxygen saturation ofblood in a patient. The system includes a system unit 105 and a sensorprobe 108, which is connected to the system unit via a wired connection112. Connection 112 may be an electrical, optical, or another wiredconnection including any number of wires (e.g., one, two, three, four,five, six, or more wires or optical fibers). In other implementations ofthe invention, however, connection 112 may be wireless such as via aradio frequency (RF) or infrared communication.

Typically, the system is used by placing the sensor probe in contact orclose proximity to tissue (e.g., skin) at a site where an oxygensaturation or other related measurement is desired. The system unitcauses an input signal to be emitted by the sensor probe into the tissue(e.g., human tissue). There may be multiple input signals, and thesesignals may have varying or different wavelengths. The input signal istransmitted into or through the tissue.

Then, after transmission through or reflection off the tissue, thesignal is received at the sensor probe. This received signal is receivedand analyzed by the system unit. Based on the received signal, thesystem unit determines the oxygen saturation of the tissue and displaysa value on a display of the system unit.

In an implementation, the system is a tissue oximeter, which can measureoxygen saturation without requiring a pulse or heart beat. A tissueoximeter of the invention is applicable to many areas of medicine andsurgery including plastic surgery and spinal surgery and patientmonitoring such as during patient transport. Applications may alsoinclude use with intensive care patients, nursing home patients, andpatients with acute illnesses. The tissue oximeter can make oxygensaturation measurements of tissue where there is no blood flow or pulse;such tissue, for example, may have been separated from the body (e.g., aflap) and will be transplanted to another place in the body.

Aspects of the invention are also applicable to a pulse oximeter. Incontrast to a tissue oximeter, a pulse oximeter requires a pulse inorder to function. A pulse oximeter typically measures the absorbancesof light due to the pulsing arterial blood.

There are various implementations of systems and techniques formeasuring oxygen saturation such as discussed in U.S. Pat. Nos.6,516,209, 6,587,703, 6,597,931, 6,735,458, 6,801,648, and 7,247,142.These patents are assigned to the same assignee as this patentapplication and are incorporated by reference.

FIG. 2 shows greater detail of a specific implementation of the systemof FIG. 1. The system includes a processor 204, display 207, speaker209, signal emitter 231, signal detector 233, volatile memory 212,nonvolatile memory 215, human interface device or HID 219, I/O interface222, and network interface 226. These components are housed within asystem unit enclosure. Different implementations of the system mayinclude any number of the components described, in any combination orconfiguration, and may also include other components not shown.

The components are linked together using a bus 203, which represents thesystem bus architecture of the system. Although this figure shows onebus that connects to each component, the busing is illustrative of anyinterconnection scheme serving to link the subsystems. For example,speaker 209 could be connected to the other subsystems through a port orhave an internal direct connection to processor 204.

A sensor probe 246 of the system includes a probe 238 and connector 236.The probe is connected to the connector using wires 242 and 244. Theconnector removably connects the probe and its wires to the signalemitter and signal detectors in the system unit. There is one cable orset of cables 242 to connect to the signal emitter, and one cable or setof cables 244 to connect to the signal detector. In an implementationthe cables are fiber optic cables, but in other implementations, thecables are electrical wires.

The connector may have a locking feature; e.g., insert connecter, andthen twist or screw to lock. If so, the connector is more securely heldto the system unit and it will need to be unlocked before it can beremoved. This will help prevent accidental removal of the probe.

The connector may also have a first keying feature, so that theconnector can only been inserted into a connector receptacle of thesystem unit in one or more specific orientations. This will ensure thatproper connections are made.

The connector may also have a second keying feature that provides anindication to the system unit which type probe of probe is attached. Thesystem unit may handle making measurements for a number of differenttypes of probes. The second keying feature will let the system unit knowwhich type of probe is connected, so that it can perform the rightfunctionality, use the proper algorithms, or otherwise make adjustmentsits the operation for a specific probe type.

In various implementations, the system is powered using a wall outlet orbattery powered, or both. Block 256 shows power block of the systemhaving both AC and battery power options. In an implementation, thesystem includes an AC-DC converter 253. The converter takes AC powerfrom a wall socket, converts AC power to DC power, and the DC output isconnected to the components of the system needing power (indicated by anarrow 254). In an implementation, the system is battery operated. The DCoutput of a battery 256 is connected the components of the systemneeding power (indicated by an arrow 257). The battery is rechargedusing a recharger circuit 259, which received DC power from an AC-DCconverter. The AC-DC converter and recharger circuit may be combinedinto a single circuit.

The nonvolatile memory may include mass disk drives, floppy disks,magnetic disks, optical disks, magneto-optical disks, fixed disks, harddisks, CD-ROMs, recordable CDs, DVDs, recordable DVDs (e.g., DVD-R,DVD+R, DVD-RW, DVD+RW, HD-DVD, or Blu-ray Disc), flash and othernonvolatile solid-state storage (e.g., USB flash drive),battery-backed-up volatile memory, tape storage, reader, and othersimilar media, and combinations of these.

The processor may include multiple processors or a multicore processor,which may permit parallel processing of information. Further, the systemmay also be part of a distributed environment. In a distributedenvironment, individual systems are connected to a network and areavailable to lend resources to another system in the network as needed.For example, a single system unit may be used to collect results fromnumerous sensor probes at different locations.

Aspects of the invention may include software executable code orfirmware (e.g., code stored in a read only memory or ROM chip). Thesoftware executable code or firmware may embody algorithms used inmaking oxygen saturation measurements of the tissue. The softwareexecutable code or firmware may include code to implement a userinterface by which a user uses the system, displays results on thedisplay, and selects or specifies parameters that affect the operationof the system.

Further, a computer-implemented or computer-executable version of theinvention may be embodied using, stored on, or associated with acomputer-readable medium. A computer-readable medium may include anymedium that participates in providing instructions to one or moreprocessors for execution. Such a medium may take many forms including,but not limited to, nonvolatile, volatile, and transmission media.Nonvolatile media includes, for example, flash memory, or optical ormagnetic disks. Volatile media includes static or dynamic memory, suchas cache memory or RAM. Transmission media includes coaxial cables,copper wire, fiber optic lines, and wires arranged in a bus.Transmission media can also take the form of electromagnetic, radiofrequency, acoustic, or light waves, such as those generated duringradio wave and infrared data communications.

For example, a binary, machine-executable version, of the software ofthe present invention may be stored or reside in RAM or cache memory, oron a mass storage device. Source code of the software of the presentinvention may also be stored or reside on a mass storage device (e.g.,hard disk, magnetic disk, tape, or CD-ROM). As a further example, codeof the invention may be transmitted via wires, radio waves, or through anetwork such as the Internet. Firmware may be stored in a ROM of thesystem.

Computer software products may be written in any of various suitableprogramming languages, such as C, C++, C#, Pascal, Fortran, Perl, Matlab(from MathWorks, www.mathworks.com), SAS, SPSS, JavaScript, AJAX, andJava. The computer software product may be an independent applicationwith data input and data display modules. Alternatively, the computersoftware products may be classes that may be instantiated as distributedobjects. The computer software products may also be component softwaresuch as Java Beans (from Sun Microsystems) or Enterprise Java Beans (EJBfrom Sun Microsystems).

An operating system for the system may be one of the Microsoft Windows®family of operating systems (e.g., Windows 95, 98, Me, Windows NT,Windows 2000, Windows XP, Windows XP x64 Edition, Windows Vista, WindowsCE, Windows Mobile), Linux, HP-UX, UNIX, Sun OS, Solaris, Mac OS X,Alpha OS, AIX, IRIX32, or IRIX64. Microsoft Windows is a trademark ofMicrosoft Corporation. Other operating systems may be used, includingcustom and proprietary operating systems.

Furthermore, the system may be connected to a network and may interfaceto other systems using this network. The network may be an intranet,internet, or the Internet, among others. The network may be a wirednetwork (e.g., using copper), telephone network, packet network, anoptical network (e.g., using optical fiber), or a wireless network, orany combination of these. For example, data and other information may bepassed between the computer and components (or steps) of a system of theinvention using a wireless network using a protocol such as Wi-Fi (IEEEstandards 802.11, 802.11a, 802.11b, 802.11e, 802.11g, 802.11i, and802.11n, just to name a few examples). For example, signals from asystem may be transferred, at least in part, wirelessly to components orother systems or computers.

In an embodiment, through a Web browser or other interface executing ona computer workstation system or other device (e.g., laptop computer,smartphone, or personal digital assistant), a user accesses a system ofthe invention through a network such as the Internet. The user will beable to see the data being gathered by the machine. Access may bethrough the World Wide Web (WWW). The Web browser is used to downloadWeb pages or other content in various formats including HTML, XML, text,PDF, and postscript, and may be used to upload information to otherparts of the system. The Web browser may use uniform resourceidentifiers (URLs) to identify resources on the Web and hypertexttransfer protocol (HTTP) in transferring files on the Web.

FIG. 3 shows a system 300 of the invention including a monitoringconsole 305, cables 310, 315, 320, and 325, and a sensor 330. Sensor 330includes a sensor unit (i.e., sensor head) 335 and a sensor housing 340.

Connectors 345 and 350 at an end of cables 315 and 310, respectively,connect the sensor to the monitoring console.

The length of the cables may vary. In a specific implementation, thelength of the cables ranges from about 1.2 meters to about 3 meters. Forexample, the cables may be about 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2,2.1, 2.2, 2.3, 2.4, or 2.5 meters long or greater. Depending on thespecific application, the cable lengths may be less than 1.2 meters. Insome applications, the cable lengths will be greater than 3 meters.

A specific application of the invention is operating room use or otherplaces where it is desirable to maintain cleanliness and sterileconditions, such as isolation units. Patients in isolation units mayhave contagious diseases or compromised immune systems. Hospitals needto ensure that patients with a contagious disease do not infect others.Items introduced near the patient must either be disposed after use orproperly cleaned. Hospitals also need to protect patients withcompromised immune systems from sources of microorganisms. In thesecases, a longer cable length, such as greater than 1.2 meters, isadvantageous because this helps to separate the patient from sources ofcontamination, such as the console. Similarly, a longer cable lengthalso minimizes contamination, such as contamination of the console, bythe patient.

The sensor including the sensor housing and sensor unit, entire lengthof cables and the connectors are packaged as a probe unit in a sterilepackage. The probe unit is detachable from the console after use and maybe disposed. A user may then open a new sterile package containing a newprobe unit. The package may be opened at the time of actual use or nearthe time of actual use so as to not contaminate the probe unit. The usercan then connect this new and sterile probe unit to the console to beginmonitoring. This disposable feature provides an additional level ofprotection in maintaining a sterile field around the patient.

Short cables pose a problem. Short cables bring whatever element theyare connected to within close proximity to the patient. Doctors andnurses must then devote additional care and time to ensure a sterilefield around the patient. This may include, for example, additionalcleansing of the elements before and after introduction to the sterilefield, or sterile drapes on the elements.

In a specific embodiment, there may be other connectors on the cablesbesides connectors 345 and 350. These other connectors allow the cablesto be separated into multiple pieces. The cables attached to the sensorcan then be disposed along with the sensor after use. The cablesattached to the console can be reused.

In an implementation, cables 320 and 325 include one or more opticalwave guides enclosed in a flexible cable jacket. The optical wave guidesmay be used to transmit light from the console and into the tissue. Theoptical wave guides may have the shape of a polygon, such as a square,rectangle, triangle, or other shape. In other cases, the optical waveguides may have circular or oval shapes. In a specific implementation,the optical wave guides are multiple strands of fiber optic cable. Theflexible cable jacket may be thin-walled PVC with or without an aluminumhelical monocoil, shrink wrap tubing, plastic, rubber, or vinyl.

In a specific embodiment, all of the fiber optic cables are enclosedwithin one end, or both ends of the flexible cable jacket. Minimizingthe number of exposed cables lowers the likelihood that the cables willget entangled. In another embodiment, the fiber optic cables are notenclosed together and instead each fiber optic cable is enclosed in itsown flexible cable jacket.

In a specific implementation, cables 320 and 325 are passive. Forexample, they will not contain any active, generative properties tomaintain signal integrity. However, in other implementations, the cablesmay include active components. The cable may include active componentsto amplify the signal at the sensor unit. For example, long lengths ofcable subject to significant attenuation may require amplification.Amplification may also be required if the monitored site contains aparticularly dense structure such as bone. In a specific implementation,radiation sources such as light emitting diodes (LEDs) may be placed inthe sensor. Thus, the cables may contain electrical wiring to transmitpower to the radiation sources.

In an implementation, cable 310 is standard electrical wiring (e.g.,copper or aluminum wire), which is stranded or solid core, or coaxialcable, or any combination of these. Cable 310 itself may containmultiple electrical wires. Further, the cable may also include acombination of one or more optical wave guides and electrical wiring. Ina specific embodiment, the electrical wiring and each optical wave guidemay be enclosed in their own separate flexible cable jacket. In anotherembodiment, multiple optical wave guides may be enclosed in a flexiblecable jacket, separate from the cable jacket enclosing the electricalwiring. For example, cables 325 and 320 may be enclosed in a cablejacket to form cable 315, while cable 310 is enclosed in a separatecable jacket. In yet another embodiment, both the optical wave guidesand electrical wiring will be enclosed in the same flexible cablejacket. For example, cables 325, 320, and 310 may be enclosed in thesame cable jacket.

In an embodiment of the invention, each opening on the sensor unit andcorresponding cable is dedicated to a particular purpose. For example, afirst opening on the sensor unit (and corresponding fiber optic cable)is dedicated to transmitting light from the monitoring console. A secondopening on the sensor unit is dedicated to transmitting a signalreceived at the second opening to the monitoring console.

Some embodiments use a particular opening and cable for multiplepurposes (e.g., both input and output) using a scheme such asmultiplexing.

In a specific embodiment, a particular opening and cable transmits anoutput to affect a reaction (e.g., sending electrical signals tostimulate muscle or other tissue). Another opening and cable transmitsthe resultant signal back to the monitoring device. In yet anotherembodiment, the openings and cables may simply detect changes andtransmit these changes back to the monitoring device. For example, theopenings and cables may carry voltage changes in the patient's skin backto the monitoring device.

In an implementation, the connectors on the cables and monitoringconsole have indicators. The indicators may be color indicators that arepainted on, or raised indicators, or both. These indicators help theuser to properly attach the cables to the monitoring console. Forexample, the indicators may include green arrows placed on the cableconnectors and monitoring console. Alignment of the arrows indicatesproper attachment of the cables. Further, there may be instructionsprinted on the console, cables, or both that instruct the user on theproper attachment of the cable.

The connectors at the end of the cables attach to the monitoring consoleand protect the cables from accidental disconnection. The connector maybe a threaded collar on a cable end that threads onto the monitoringconsole. Alternatively, the connector may be a lug closure, press-fit,or snap-fit.

In an implementation, the console is portable. Thus, the console can behand-carried or mounted to an intravenous (IV) pole. A portable consolecan follow a patient anywhere in the hospital, eliminating the need tochange connections whenever a patient is moved. Moreover, a portabledesign facilitates use and assessments in numerous other locationsbesides a hospital.

A portable console is typically battery-operated. The battery istypically a rechargeable type, such as having nickel cadmium (NiCd),nickel metal hydride (NiMH), lithium ion (Li-Ion), lithium polymer, leadacid, or another rechargeable battery chemistry. The system can operatefor a certain amount of time on a single battery charge. After thebattery is drained, it may be recharged and then used again.

The portable console may also have a power-saving feature. This reducesbattery consumption during continuous measurements. The power-savingfeature may, for example, darken the console's display screen after acertain time of inactivity. The time may be approximately five, ten,fifteen, or twenty minutes. Alternatively, the user may program thetime.

In a specific implementation, the portable console weighs approximately4.3 kilograms. However, the weight may vary from about 3 kilograms toabout 7 kilograms including, for example, 3.5, 4, 4.5, 5, 5.5, 6, 6.5,or more than 7 kilograms.

In another implementation, the console is not hand-held or portable. Theconsole may be a large, nonportable device that is attached to a wall orsecured to a stand or surface. In this implementation, the system istypically connected to AC power. A battery may be used as a back-up tothe AC power.

In a specific implementation, the console provides alerts. The alertsmay be visual (e.g., a flashing light on a display of the console),audible, or both. Visual alerts may be designed so that they areviewable from any location (e.g., a flashing light on the top of theconsole). In a chaotic and noisy situation, this allows users to quicklyrespond to a patient. These alerts may signal a problem with the system.This includes, for example, insufficient signal strength, kinks or sharpbends in the cable, debris on the sensor unit, debris on a couplingsurface between the cable and the console, insufficient electricalpower, a low battery, an improperly attached cable, or other problem.

An alert may also signal when the system is ready for patientmonitoring. The alerts may also provide warnings at certain oxygensaturation levels. Different alerts may be used depending on the type ofproblem detected by the system. Different alerts include differentcolors, sounds, and intensities of colors and sounds.

The console may provide an alert when the sensor unit is placed in asuitable location for a measurement. The alert may vary in intensitydepending on the suitability of the location. The alert may be audible,or visual, or both. An audible alert allows the user to determine thesuitability of a location without having to look away from the patient.

The alerts may be user-programmable. That is, users may set which alertsare enabled, the threshold at which they are activated, and theintensities of the alerts. For example, a user may decide to enable theoxygen saturation alert, set the alert to occur if and when the oxygensaturation level falls below a certain value, and set the volume levelof the alert.

The console may also include a mass storage device to store data. Massstorage devices may include mass disk drives, floppy disks, magneticdisks, fixed disks, hard disks, CD-ROM and CD-RW drives, DVD-ROM andDVD-RW drives, flash and other nonvolatile solid-state storage drives,tape storage, reader, and other similar devices, and combinations ofthese.

The stored data may include patient information. This includes, forexample, the patient's name, social security number, or otheridentifying information, oxygen saturation measurements and the time anddate measured. The oxygen saturation measurements may include high, low,and average values and elapsed time between measurements.

The above drives may also be used to update software in the console. Theconsole may receive software updates via a communication network such asthe Internet.

In an implementation, the console also includes an interface fortransferring data to another device such as a computer. The interfacemay be a serial, parallel, universal serial bus (USB) port, RS-232 port,printer port, and the like. The interface may also be adapted forwireless transfer and download, such as an infrared port. The systemtransfers data without interruption in the monitoring of the patient.

A screen on the console displays the patient's data. The screen may be aflat panel display such as a liquid crystal display (LCD), plasmadisplay, thin film transistor liquid crystal display (TFT LCD),electro-luminescent (EL), or organic light emitting diode (OLED)display. The screen may include a touch screen interface. Such touchscreen interfaces are easier to clean compared to keypads if they becomecontaminated because they do not contain mechanical parts.

The screen may display numbers, text, graphics, and graphical trends incolor. Different colors may correspond to different measurements orthreshold levels. The text and numbers may be displayed in specificlanguages such as English, Spanish, French, Japanese, or Tagalog. Thedisplayed language is user-programmable.

In a specific implementation, the screen displays data related to asingle regional oxygen saturation reading. For example, this may includea single plot or graph.

Users can also vary the size of the displayed information on theconsole's screen. This allows the display to be viewed at a distance,increases the viewing angle, and allows users with vision limitations tosee the information.

In a specific implementation, the console includes one or morenear-infrared radiation sources. In other implementations, the radiationsources may be external to the console. For example, the radiationsources may be contained within a separate unit between the console andsensor. In yet another implementation, some radiation sources may bewithin the console while other radiation sources are external to theconsole.

These radiation sources may be near-infrared lasers. In a specificimplementation, there are four near-infrared lasers located within theconsole. In other implementations, there may be less than four radiationsources or more than four radiation sources. For example, there may be2, 3, 5, 6, 7, 8, 9, 10 or more than 10 radiation sources. Theseradiation sources may generate approximately 100 milliwatts of power.This allows photodiodes, which in an implementation are located at thesensor, to receive light where the signal-to-noise ratio is greater than10. However, the power can range from about 70 milliwatts to about 130milliwatts. For example, the power may be 75, 80, 85, 90, 95, 100, 105,110, 115, 120, 125, or more than 130 milliwatts. Depending on theapplication, the power may be less than 75 milliwatts such as 30milliwatts.

FIG. 4 shows an example of a wireless implementation of the invention. Asystem 400 includes a monitoring console 405 at a field location 410which transmits 415 the patient's data to a receiving location 420. Thefigure shows the monitoring console transmitting the data, using forexample, a modem in the monitoring console. However, in anotherimplementation, a sensor unit 425 may wirelessly transmit the data thereceiving location.

In the figure, the field location is in an ambulance. The ambulance istransporting a patient 430 to a hospital. In other implementations, thefield location may be in another type of vehicle such as a car,automobile, truck, bus, train, plane, boat, ship, submarine, orhelicopter. The field location may also be on a battlefield, at anaccident scene such as a car accident, at a natural disaster scene suchas an earthquake, hurricane, fire, or flood, in a patient's home, at apatient's place of work, or in a nursing home.

The receiving location also varies. The receiving location may be ahospital, clinic, trauma center, physician's home or office, or anurse's home or office. The monitoring console or sensor unit may alsotransmit to multiple receiving locations. For example, data may betransmitted to both the hospital and the physician's home.

A variety of devices may receive the data. This includes, for example, amonitoring console, other monitoring stations, mobile devices (e.g.,phones, pagers, personal digital assistants (PDAs), laptops), orcomputers, or combinations of these.

The distance between the field and receiving location may vary. Thefield and receiving location could be in different countries, states,cities, area codes, counties, or zip codes. In other cases, the fieldlocation and receiving location may be in different parts of the sameroom or in different rooms in the same building.

The wireless transmission may be analog or digital. Although FIG. 4shows the system transmitting data directly to the receiving location,this is not always the case. The system may relay data to the receivinglocation using intermediaries. For example, satellites may rebroadcast atransmission. While in one embodiment, a communication network is theInternet, in other embodiments, the communication network may be anysuitable communication network including a local area network (LAN), awide area network (WAN), a wireless network, an intranet, a privatenetwork, a dedicated network, phone lines, cellular networks, a publicnetwork, a switched network, and combinations of these and the like.Wireless technologies that the system may employ include: Wi-Fi,802.11a, 802.11b, 802.11g, 802.11n, or Bluetooth, or combinations ofthese and the like. The system also has the ability to switch from onecommunication technique to another if, for example, the current networkis unreliable or there is interference. The switch may either beautomatic or manual.

The system's ability to wirelessly transmit data offers severaladvantages. It reduces the time to treatment for a patient. For example,data sent from an ambulance en route to a hospital allows a physician atthe hospital to mobilize personnel and equipment before the patient evenarrives. Another advantage is long-distance monitoring. For example,patients may use the system in their own homes. The system will then, ona continuous basis if desired, transmit data to a receiving location,such as a hospital. A nurse or physician at the hospital can then reviewthe data. If the data indicates a problem with the patient, then thehospital can dispatch an ambulance to the patient's home.

FIG. 5 shows a perspective view of a sensor 500 in accordance with anembodiment of the present invention. Sensor 500 includes a sensorhousing 501. The sensor housing includes a detector housing 510, asource housing 515, and a base 520. The detector and source housings arecoupled to the base. A small separation 535 exists between the detectorand source housings. In a specific implementation, a cable 536 enters anedge 539 of the detector housing. Cables 537 and 538 enter the topsurface of the source housing. Cable fastener 505 fastens the cablestogether.

Cables 537 and 538 each enter the top surface of the source housing andthrough cavities in the source housing. In other implementations, one orboth cables may enter at an edge of the source housing. Within eachcavity is a source structure that the cables enter. The cavities areexposed through an opening on the bottom surface of the base. The cablesare secured to the top surface of the source housing with, for example,an adhesive. The adhesive may be a tape, a glue such as epoxy, or asealant such as a silicon sealant. Stitches may also be used to securethe cables.

In the implementation shown, cable 536 enters through edge 539 of thedetector housing. In other implementations, cable 536 may enter throughthe top of the detector housing. Cable 536 enters through a cavity inthe detector housing and connects to detector structures (not shown)which are embedded the detector housing. Cable 536 is secured to thesensor housing with, for example, an adhesive. The adhesive may be atape, a glue such as epoxy, or a sealant such as a silicon sealant.Stitches may also be used to secure the cable.

In a specific embodiment, the sensor housing is made of foam,specifically, one or more pieces of ⅛-inch (3.18 millimeters) thickcross-linked polyethylene foam coated on one side with a medical-gradeadhesive (e.g. pressure sensitive medical-grade acrylic adhesive) with awhite release liner (e.g., 92 pound, bleached kraft paper, polycoated,silicone treated on one side), such as that made by Scapa North Americaof Windsor, Conn. and available as part number 0399003. In this specificembodiment, thickness of the foam is determined under American Societyfor Testing Materials (ASTM) D1005-95.

In this specific embodiment, the adhesive properties may further includea thickness of 1.5 mils as determined under ASTM D1000-93, a value oftearing bond for adhesion to steel, and a value of tearing bond foradhesion to backing as determined under the Pressure Sensitive TapeCouncil (PSTC) test method number 1 with a 30 minute dwell time.

In other embodiments, the sensor housing is made of polystyrene, paper,corrugated fiberboard, polypropylene, polyurethane, an inflated airpillow, silicon, latex, rubber, or molded pulp. The sensor housing mayhave a 20 to 60 type A durometer.

Furthermore, the individual parts of the sensor housing may be made ofdifferent materials. For example, the base may be made of polyethylenefoam while the source and detector housing is made of rubber.

In an implementation, the detector housing, source housing, and base allhave the shape of a polygon. For example, the base may have the shape ofa rectangle with rounded corners. The detector housing and sourcehousing may have the shape of a square with rounded corners. However, inother implementations, the shapes may not all be composed of generallystraight line segments. For example, the shapes may include convex edgesand thus resemble circles, ovals, or ellipses. The shapes may alsoinclude concave edges and combinations of concave edges, convex edges,and straight edges.

In an implementation, the sensor housing is flexible. The flexibilityallows the sensor housing to conform to the shape of the sensor unit(i.e., detector and source structures) and the patient's skin. Thisallows the sensor unit to be shielded from ambient light. Source lightis also prevented from escaping. The sensor unit uses light transmittedby an optical wave guide, such as a fiber optic cable, to obtainsensitive measurements. If light from the sensor unit escapes throughthe sensor housing, the sensor unit may not detect this light. Likewise,ambient light entering the sensor housing will also result in inaccuratereadings. When the sensor housing conforms it creates a dark environmentwithin the sensor housing that enables accurate readings. The sensorhousing's flexibility is a function of its size and material type.

In an implementation, one or more light-shielding layers may be includedwith the sensor housing to shield ambient light and to protect sourcelight from escaping. These light-shielding layers may be constructed ofpolypropylene film metalized with aluminum and coated with a pressuresensitive adhesive. In other implementations, the layers are made of afoil, a mirror, or made of other materials such as gold, titaniumdioxide, or a composite of materials to block or reflect light. Otherexamples include a light-reflective tape, a material coated withlight-shielding paint, a material impregnated with light-reflectivematerial, or a light-reflective fabric. The sensor unit itself may becovered or made with a light-reflective material.

Small separation 535 may be located at approximately a midpoint of thesensor housing. The separation may be about 0.5 millimeters to about 5millimeters. For example, the separation may be 0.6, 0.7, 0.8, 0.9, 1,2, 3, 4, or 6, or more than 6 millimeters. In other applications, theseparation will be less than 0.5 millimeters. The separation is locatedbetween the detector and source housings. The sources are on one side ofthe separation while the detectors are on the other side of theseparation. The separation allows the base to easily fold inward suchthat the source and detector structures are angled in towards eachother. This allows the detectors to better receive the light after ithas been transmitted through the tissue.

The separation also allows the base to more easily conform to curvedsurfaces, such as the curved surface of a patient's forehead. Moreover,the increased flexibility allows the sensor to be used on a variety ofsurfaces which have varying degrees of curvature. In an implementation,the sensor is placed on a patient's forehead to measure cerebral tissueoxygen saturation. Some foreheads are flat and other foreheads are morerounded. The sensor, because of its flexibility, may be equallyeffective on either forehead.

In other implementations, a cut, score, or perforations in the sensorhousing may be used to impart an additional degree of flexibility. Thecut, score, or perforation may be made at a midpoint on the top surfaceof the sensor, between the source and detector structures, or at someother location. For example, the source and detector housings may be asingle unit. That is, the source and detector structures may be embeddedin a single piece of foam. A score on the top surface of the foam,between the source and detector structures will allow the sensor toconform to a curved surface as the source and detector will bend aroundthis score.

The figure shows the sensor as a single integrated unit. An advantage ofusing a single sensor probe pad is to lower the cost (i.e., half thecost of using two such pads) and also to make it easier to use. A userdoes not have to position or otherwise manipulate or align multiplesensors to attach to a patient. However, depending on the situation andpatient (e.g., patient that has slight thicker skull), then a multiplesensor pad arrangement discussed below could be used.

Also, the arrangement of the sources and detectors are such that the padhas a compact structure and will not run across a person's forehead.

FIG. 6 shows a top view of a sensor 605. A base 610 extends past edgesof a detector housing 615 and a source housing 620.

The base may extend past the edges from about 1 millimeter to about 10millimeters. For example, the extension may be about 2, 3, 4, 5, 6, 7,8, or 9 millimeters, or more, or less than 1 millimeter. In a specificimplementation, the base may not extend past the edges of the detectorand source housing. Instead, the edge of the base may overlap with edgesof the detector and source housing. In other implementations, the baseonly extends past one, two, or three edges of the detector and sourcehousing.

In a specific implementation, the base extends past the left and rightedges of the detector and source housings for a distance that is greaterthan the extension past the top edge of the source housing and thebottom edge of the detector housing as shown in FIG. 6. However, this isnot always the case. For example, the base may extend past the edges ofthe source and detector housings by the same amount. In otherimplementations, the base may extend past the top edge of the sourcehousing and the bottom edge of the detector housing for a distance thatis greater than the extension past the left and right edges of thedetector and source housings.

The edges of sensor may serve as locator guides. In an implementation,the user places the sensor on the patient's forehead such that an edge625 is approximately 1 centimeter away from the midline of the patient'sforehead. An edge 630 may also used as locator guide. For example, edge630 may be placed on the patient's forehead such that edge 630 isapproximately 1 centimeter above the patient's eyebrow. When the deviceis properly attached, the patient should not feel strong light which isa sign of being away from the patient's frontal sinus.

In a specific implementation, there may be instructions including text,diagrams, or both printed on the sensor housing that instruct the useron the proper placement of the sensor. The text, diagrams, or both mayinclude a ruler in English units, metric units, or both to help the userproperly position the sensor.

FIG. 7a shows a bottom view of the sensor. In a specific implementation,a sensor housing base 704 has openings 720 a, 720 b, and 745. Openings720 a and 720 b are coupled to cavities 721 a and 721 b. Sourcestructures 715 a and 715 b may be located in cavities 721 a and 721 b,respectively, and are exposed through the openings.

Detector structures 730 a, 730 b, 730 c, and 730 d occupy cavity 745 andare exposed through opening 745. A light diffusing layer 729 coversdetector structures 730 a and 730 b. An adhesive film 760 covers thebottom surface of the sensor housing base. A release liner 765 with apull-tab 770 covers the adhesive film.

In a specific implementation, the sensor unit includes source structures715 a and 715 b and detector structures 730 a, 730 b, 730 c, and 730 d.In one embodiment, the source structures, detector structures, or bothmay be packaged into a single reusable physical unit while the sensorhousing is separately packaged as disposable physical unit. Separatingthe source and detector structures from the sensor housing offersseveral benefits. For example, the source structures may include laserdiodes and the detector structures may include photodiodes. Theseelements may be more expensive than the sensor housing which istypically made of foam. Reusing the more expensive elements may allowfor significant cost savings. Disposing the less costly sensor housingafter use and replacing with a new sensor housing from a sterile packageprotects the patient from contamination.

In another embodiment, they may not be packaged into a single physicalunit. For example, the source structures may be packaged in a physicalunit that is separate from the detector structures. In yet anotherembodiment, there is no physical packaging of source structures anddetector structures. Instead, each source structure may be individuallyplaced in the sensor and likewise, each detector structure may beindividually placed in the sensor.

The implementation shown has a total of three openings (720 a, 720 b,and 745) on the sensor housing base. In other implementations, there maybe more or less openings. For example, there may be one or two openingsor three, four, five, six, seven, eight, or more than eight openings.

In the implementation shown, the two source structures each have theirown opening. The four detector structures are grouped together in asingle opening. However, this is not always the case. The sources may begrouped together in a single opening while the detectors may each havetheir own separate opening. In another embodiment, all the sources anddetectors may be grouped together into a single opening. In yet anotherembodiment, each source and each detector may have their own opening.

In a specific embodiment including fiber optic cables, one fiber opticcable connects to each source opening on a bottom surface of the sensorunit. The bottom surface faces and contacts the area of the person,animal, or other living thing that is being monitored. There is anynumber of source openings. This includes, for example, one, two, three,four, five, six, seven, eight, or more than eight source openings. Forexample, if the bottom surface has two source openings there will be twofiber optic cables for transmitting radiation from the monitoringconsole. Similarly, if the bottom surface has six source openings, therewill be six fiber optic cables.

In a specific implementation, each source structure includes a strand offiber optic cable to transmit light into the tissue while each detectorstructure includes a photodiode to receive the transmitted light. Forexample, opening 715 a holds one end of a first fiber optic cable whileopening 715 b hold one end of a second fiber optic cable. Each detectorstructure 730 a, 730 b, 730 c, and 730 d has a photodiode.

By having the photodiode (or photodetector) embedded in the sensor probehousing, instead of using just an end of a fiber optic cable connectedto a photodiode in the system unit, this places each photodiode muchcloser to the site that is being measured. This allows much moreaccurate readings and allows detection of signals have a much lowersignal strength, such as those transmitted and reflected off of tissuebeneath the skull.

Running source signals from one or more signal emitters in the systemunit through fiber optic cables provides signals with sufficientstrength to penetrate the skull. By having the signal emitters in thesystem unit, this reduces the cost of the sensor probe. The probe istypically thrown away after one use. Thus, reducing the number ofemitters and photodiodes (but having sufficient numbers to allow foraccurate measurements) will reduce the cost of a probe.

Electrical wires enclosed in a cable 746 are coupled to each of theembedded photodiodes. Thus, if there are four photodiodes, there will befour electrical signal wires and one ground wire. These electrical wirescan then carry the signal generated by the photodiodes back to theconsole. The signals carried by the electrical wires may includeelectrical signals converted from the lights received by the detectors.Typically, the power of these electrical signals will be less than 10milliwatts. Typically, voltage in the wires will be less than 10 volts,and current less than 1 milliamp. However, in other implementations, thepower may be greater than or equal to 10 milliwatts. Similarly, thevoltage may be greater than or equal to 10 volts and the current may begreater than or equal to 1 milliamp.

In another embodiment, the photodiodes may be external to the sensor.For example, the photodiodes may be located in the console, in aseparate unit between the sensor and the console, or there may be acombination of photodiodes that are internal and external to the sensor.

The example in FIG. 7a shows all the detector structures (730 a, 730 b,730 c, and 730 d) having the same cross-sectional area. In a specificimplementation, the cross-sectional area of each detector structure isabout 50 square millimeters. However, the cross-sectional area may rangefrom about 45 square millimeters to 55 square millimeters. For example,the cross-sectional area may be 46, 47, 48, 49, 51, 52, 53, or 54 squaremillimeters. In some implementations, the cross-sectional area will beless than 45 square millimeters. In other implementations, thecross-sectional area will be greater than 55 square millimeters.

Furthermore, in other implementations, the detector structures may notall have the same cross-sectional areas. For example, the detectorstructures nearest the sources may have a smaller cross-sectional areathan the detectors farthest from the sources. In another embodiment, itmay be the opposite. That is the detector structures nearest the sourcesmay have a larger cross-sectional area than the detectors farthest fromthe sources

The source and detector structures are typically embedded in the sensorhousing such that they do not touch an edge of the sensor housing base.This helps to ensure that light does not escape from the sourcestructures. It also helps to ensure that ambient light is nottransmitted to the detector structures. However, in other embodiments,the source and detector structures may touch an edge of the sensorhousing base.

In a specific implementation, cable 746 enters at an edge of the sensorat a midpoint between the detector structures and source structures andat an edge nearest the detectors. Thus, cable 746 divides the sensorinto a left-hand side and a right-hand side. The left-hand side andright-hand side are mirror images, i.e., they are symmetrical. Each sideincludes a source structure and two detector structures. In otherimplementations, the cable may not enter at a midpoint of the sensor.For example, the cable may enter at a different edge near the detectors.In yet another implementation, the cable may enter at an edge that isfarthest from the detectors.

In an implementation, light diffusing layer 729 is attached to thebottom of the sensor housing base. It may be attached using an adhesiveor it may be embedded within the sensor housing base. The lightdiffusing layer is typically about 0.1 millimeter thick, but can rangefrom about 0.05 to about 0.2 millimeters. The light diffusing layertypically absorbs about nine-tenths of light at the wavelengths used ina typical implementation of the invention.

In an implementation, the light diffusing layer is permanently attachedto the sensor. In other implementations, a user may detach the lightdiffusing layer and attach a different light diffusing layer having adifferent size, different optical properties, different thickness, orcombinations of these. This allows, for example, the user to customizethe sensor according to a particular patient's anatomy.

The example in the figure shows two out of the four detector structurescovered by the light diffusing layer. Thus, one-half or 50 percent ofthe detector structures are covered in this implementation. In otherimplementations, the percentage may be different. For example, thepercentage of detectors covered may be about 5, 10, 20, 30, 40, 50, 60,70, 80, or 90 percent, or greater.

In the implementation shown, the two detectors covered by the lightdiffusing layer are the two detectors that are closest to the sourcestructures. In another implementation, the detectors covered by thelight diffusing layer may be the detectors farthest from the sourcestructures. In yet another implementation, there may be a differentnumber of detector structures covered by the light diffusing layerincluding, for example, one, two, three, four, five, six, or more thansix detector structures.

The light diffusing layer may be a semitranslucent film having the shapeof a polygon, such as a rectangle or square. In another implementation,the shape may include curved edges such as a concave or convex edges.The shape may be an oval, ellipse, or circle. Furthermore, the shape maybe a combination of curved and straight edges.

The light diffusing layer may be made of plastic, nylon, crystallizedpolymers (e.g., polypropylene or polyethylene), polyethyleneterephthalate (PET), or glass. In a different implementation, the lightdiffusing layer may be a film with a pattern of perforations to diffusethe light.

In another implementation, the light diffusing layer may be placeddirectly on the two detector structures as opposed to being attached tothe sensor housing base. The light diffusing layer may be two separatepieces that each has the same shape as the detector structures. Thus, ifthe detector structures have a circular shape, then the light diffusinglayers may be circular as well.

In yet another implementation, the light diffusing layer may be alight-diffusing coating painted onto the detector structures.

The light diffusing layer attenuates the light back-reflected from theshallow layer of the tissue. The shallow layer of the tissue includesthe scalp, skull, and cerebrospinal fluid. This helps to make sure thatthe signal level received by the two near detectors (i.e., detectors 730a and 730 b, the detectors nearest the sources) are within the dynamicalrange of the photodiodes.

In a specific implementation, there may not even be a light diffusinglayer. Instead, the back-reflected light may be compensated for throughmathematical computations at the console or the received signals may beattenuated using some other mechanism.

Each source structure and detector structure has a reference point. Thereference points may be the centers of the sources and detectors if, forexample, the sources and detectors have circular shapes. Alternatively,the reference point may be defined as some other point, so long as thedefinition is consistent among the sources and detectors. A line 725that is parallel to an x-axis 750 a passes through the reference pointof each source structure.

A line 735 that is parallel to x-axis 750 a passes through a referencepoint of detector structures 730 a and 730 b. A line 740 that isparallel to x-axis 750 a passes through a reference point of detectorstructures 730 c and 730 d.

In the described embodiment, a distance y1 between line 725 and line 735and along y-axis 750 b describes a near-distance for the source anddetector separation. A distance y4 between line 725 and line 740 andalong y-axis 750 b describes a far-distance for the source and detectorseparation. The near-distance y1 is different from the far-distance y4.Generally, y4 has a greater length than y1.

It should be appreciated that distance y1 and distance y4 may varywidely depending upon any number of factors. These factors include, butare not limited to, the number of source and detector structures, theoverall size of the source and detector structures, the depth of tissuebelow the skin surface to be measured, and the application for which thesensor unit is intended. In general, y1 is approximately 30 millimeters.The difference between y1 and y4, i.e., y2, is approximately 10millimeters. This then results in a distance y4 of approximately 40millimeters.

In a specific implementation, the distance y2 between the detectorstructures will be less than the distance y1 or y4 between the sourcestructures and detector structures. For example, if the distance betweenthe detector structures is d then a distance from a source structure toa detector structure will be greater than d. However, in otherimplementations, the distance between the detector structures will begreater than a distance from a source structure to a detector structure.

A line 705 that is parallel to y-axis 750 b passes through a referencepoint of source structures 715 a, and detector structures 730 a and 730c. A line 710 that is parallel to y-axis 750 b passes through areference point of source structure 715 b, and detector structures 730 band 730 d.

In the described embodiment, a distance x2 between line 705 and line 710and along x-axis 750 a is approximately 10 millimeters. It should beappreciated that distance x2 may vary widely depending upon any numberof factors. These factors include, but are not limited to, the number ofsource and detector structures, the overall size of the source anddetector structures, the depth of tissue below the skin surface to bemeasured, and the application for which the sensor unit is intended. Forexample, in another implementation, x2 may be 5 millimeters.

A distance x1 along x-axis 750 a is between a side edge of the sensorhousing base and line 750. A distance x3 along x-axis 750 a is betweenan opposite side edge of the sensor housing base and line 710. These twodistances describe how far from an edge of the sensor housing the sourceand detector structures are offset along the x-axis. In animplementation, x1 is the same as x3. However, in another implementationx1 is different from x3.

A distance y3 along y-axis 750 b is between a top edge of the sensorhousing base and line 725. A distance y5 along y-axis 750 b is between abottom edge of the sensor housing base and line 740. These two distancesdescribe how far from an edge of the sensor housing the source anddetectors are offset along the y-axis. In an implementation, y3 isdifferent from y5. Y3 may be greater or less than y5. In anotherimplementation, y3 and y5 may be the same.

A distance x4 and a distance y6 as shown in FIG. 7a describes the widthand length, respectively, of the sensor housing base. In animplementation, x4 is approximately 42 millimeters and y6 isapproximately 70 millimeters.

Table A below shows several implementations for the dimensions discussedabove.

TABLE A First Implementation Second Implementation Dimension(millimeters) (millimeters) x1 11  7.7-14.3 x2 10  7-13 x3 11  7.7-14.3x4 32 29.4-54.6 y1 30 21-39 y2 10  7-13 y3 11  7.7-14.3 y4 40 28-52 y522 15.4-28.6 y6 73 49-91

In a specific implementation, the bottom surface area of the sensor baseis greater than the combined areas of the openings for the source anddetector structures. The area of the sensor base may be about 4 to 7times greater than the combined areas of the openings. For example, itmay be 4, 4.1, 4.3, 4.5, 4.7, 4.9, 5, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7,5.8, 5.9, 6, 6.1, 6.3, 6.5, 6.7, 6.9, or more than 7 times greater thanthe combined areas of the openings. Depending on the specificapplication, the bottom surface area of the sensor base may be less than4 times greater than the combined areas of the openings.

Adhesive film 760 allows the sensor housing to adhere to the tissuebeing monitored. Thus, it may be flexible and elastic so that it canconform to the surface of the tissue. In an implementation, the adhesivefilm is nonirritating to the human skin. A user can remove the sensorhousing without leaving any residue or causing any damage to thepatient's skin. In a specific implementation, the adhesive film may alsobe impregnated with antibiotics. This aids in preventing infections tosensitive skin.

In a specific embodiment, the adhesive film is matte finish, 3 miltransparent polyethylene, coated with a hypoallergenic, pressuresensitive acrylate adhesive. In other embodiments, the film is thickeror thinner, opaque or nontranslucent, or includes an alternativeadhesive material (e.g., latex or silicone-based). The adhesive film maybe a coating. The coating may be deposited using a brush or spray. Thecoating may be deposited as a series of small dots or lines. It maycover the entire bottom base of the sensor housing, or it may only covera portion of the bottom base.

The adhesive film has openings. These openings match openings 720 a, 720b, and 745 on the sensor housing base. The adhesive film is roughlyrectangular in shape with rounded corners. The shape of the adhesivefilm typically matches the shape of the sensor housing base. However, ina specific implementation the adhesive film may extend past an edge ormultiple edges of the sensor housing base. In another implementation,the adhesive film may not extend to an edge or multiple edges of thesensor housing base. This implementation allows a user to remove thesensor housing from the patient by grasping an unsecured edge of thesensor housing base to peel it away from the patient's tissue.

A release liner 765 with a pull-tab 770 is coupled to the adhesive film.The pull-tab is positioned at an edge adjacent to cable 746. The userremoves the release liner to expose the adhesive film prior to adheringthe sensor housing on the patient's skin. The release liner, in aspecific embodiment, is a silicone treated, polyethylene coated,bleached kraft paper. In other embodiments, the liner is made of othermaterials such as claycoated paper, polycoated paper, polyester, orpolypropylene, amongst others. It may be treated with a material such assilicone to allow for easy removal from the adhesive film.

In a specific embodiment, the release liner is a single piece with apull-tab to allow removal of the liner from the adhesive film in onepiece. In this embodiment, the pull-tab is generally at the edge of therelease liner closest to the cable. However, the pull-tab can be onother edges of the release liner. In another specific embodiment, therelease liner is in multiple sections. For example, the release linermay be trisected to allow removal of the release liner in stages. Otherembodiments could include fewer or more sections of liner, with orwithout pull-tabs. In lieu of or in addition to a pull-tab, the linermay be split to aid in removal of the liner from the adhesive film.

In a specific implementation, the four detectors are positioned at thevertices of a square; however, the detectors may be positioned atvertices of any quadrilateral. The sources are arranged linearly andsymmetrically distanced from the detectors.

In a symmetrical arrangement, the sensors are arranged so there is afirst distance between a first detector and a first source and a seconddistance between the first detector and a second source, where the firstand second distances are equal. In another example, the sensor openingsare arranged so there is a first distance between a first source and afirst detector and a second distance between the first source and asecond detector, where the first and second distances are equal.

In another symmetrical arrangement, the sensors are arranged so there isa first distance between a first source and a first detector. There is asecond distance between the first source and a second detector. There isa third distance between a second source and the first detector. Thereis a fourth distance between the second source and the second detector.The arrangement is symmetrical the first distance is equal to the fourthdistance, and the second distance is equal to the third distance.

In another implementation, the arrangement of sources and detectors isasymmetrical. An asymmetrical arrangement of sources and detectors isdiscussed in U.S. Pat. No. 7,355,688, which is incorporated byreference. Any of the asymmetrical arrangements of sources and detectorsdiscussed in that patent is applicable to the sources and detectors inthis application.

FIG. 7b shows an example of an asymmetrical arrangement of sensors. Asensor head 772 includes sources 775 a and 775 b and detectors 778 a,778 b, 778 c, and 778 d. Sources 775 a and 775 b are arranged such thatthey are in an offset arrangement relative to detectors 778 a, 778 b,778 c, and 778 d. That is, source 775 a and 775 b are not equidistant todetectors 778 a, 778 b, 778 c, and 778 d relative to at least one axis.Detectors 778 a and 778 b are arranged such that a line 780 of detectors778 a and 778 b is approximately parallel to an x-axis 782 a. Typically,line 780 passes through a reference point of each detector 778 a and 778b. Sources 775 a and 775 b are arranged such that a line 784 of source775 a is parallel to a line 786 of source 775 b, but is not coincidentwith line 784. Line 784 passes through a reference point of source 775 aand is parallel to x-axis 782 a, while line 786 passes through areference point of source 775 b and is parallel to x-axis 782 a.

A distance y20 between line 784 and line 780 along a y-axis 782 bdiffers from a distance y21 between line 786 and line 780. Althoughdistance y20 is shown as being greater than distance y21, it should beappreciated that distance y21 may instead be greater than y20. Thedifference between distance y20 and distance y21 is generallycharacteristic of the offset arrangement, or substantially unbalancedarrangement, of sources 775 a and 775 b relative to detectors 778 a and778 b. In other words, there is effectively a lack of symmetry in theplacement of sources 775 a and 775 b.

Distance y20 may be approximately 34 millimeters, while distance y21 maybe approximately 30 millimeters. It should be appreciated that distancey20 and distance y21 may vary widely depending upon any number offactors. The factors include, but are not limited to, the overall sizeof the sources and detectors, the overall size of the sensor head, andthe application for which sensor head 772 is intended. In general, thedifference between distance y20 and distance y21 (i.e., y22) ranges fromabout 3 to 5 millimeters. For example, y22 may be 3.1, 3.2, 3.3, 3.4,3.5, 3.6, 3.7, 3.8, 3.9, 4, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9,or more than 5 millimeters. In other implementations, y22 may be lessthan 3 millimeters.

As a further example, in an asymmetrical arrangement, the sensors arearranged so there is a first distance between a first detector and afirst source and a second distance between the first detector and asecond source, where the first and second distances are not equal. Inanother example, the sensor openings are arranged so there is a firstdistance between a first source and a first detector and a seconddistance between the first source and a second detector, where the firstand second distances are not equal.

In another asymmetrical arrangement, the sensors are arranged so thereis a first distance between a first source and a first detector. Thereis a second distance between the first source and a second detector.There is a third distance between a second source and the firstdetector. There is a fourth distance between the second source and thesecond detector. The arrangement is asymmetrical when the first distanceis not equal to the fourth distance, and the second distance is notequal to the third distance.

In other implementations, two or more sensor probes of the invention maybe used. Multiple sensors may be useful when, for example, multipletissue oxygen saturation readings are desired at different regions. Whenusing two probe pads, there will be a total of four sources and eightdetectors. These probe pads may be placed on different sides of apatient's head. An advantage of using greater number of sources anddetectors is to allow for taking more detailed and accuratemeasurements.

Even greater number of pads (more than two) may be used, but there istypically a limited amount of surface area on a person's head in whichto place the pads. Therefore, there is an advantage to having greaternumbers of sources and detectors for a single pad.

When multiple sensor probe pads are used, each pad may have asymmetrical or asymmetrical arrangement of sources and detectors asdiscussed above.

FIG. 8 shows a front view of the sensor with dimensions to indicate thethickness of the various parts of the sensor. A distance y10 representsthe thickness of the base. A distance y11 represents the thickness ofthe detector and source housings. A distance y12 represents the totalthickness of the sensor housing.

In a specific implementation, the detector and source housings arethicker than the base. Placing the thicker detector and source housingson opposite sides of the thinner base as shown in previous figures helpsto ensure the flexibility of the sensor as the detector and sourcehousings can rotate towards each other. At the same time, the thickerdetector and source housings can properly support the embedded detectorstructures and source structures. The entire surface area of the basecan then fully contact the tissue to create a dark environment. Anoverly thick base presents problems. Source light may escape and ambientlight may enter when such a base is placed on a curved surface. Due tothe thickness, such a base may not have sufficient flexibility tocompletely contact the surface. Instead, a crease may form which letssource light escape and ambient light in. This could then result ininaccurate readings.

The exact thickness of the source and detector housings and base willvary with the size of the embedded source and detector structures. Asnoted, typically, source and detector housings will be thicker than thethickness of the base. For example, if the thickness of an uncompressedsource or detector housing is x, then the thickness of the uncompressedbase should be less than x.

In a specific implementation, the detector and source housings mayinclude several layers of cushioning material such as polyethylene foamin order to properly support the source and detector structures. Forexample, the detector and source housings may be made with 2, 3, 4, 5,or more layers of 3.18 millimeter thick polyethylene foam. In animplementation, the thickness of the detector and source housing isapproximately three times the thickness of the base. For example, thehousings may be two, four, five, or more than five times as thick as thebase. Table B below shows several implementations for the thickness ofthe sensor housing.

TABLE B First Implementation Second Implementation Dimension(millimeters) (millimeters) y10 3.18 2.2-4.1  y11 9.54 6.7-12.4 y1212.72 8.9-16.5

FIG. 9 shows a side view of the sensor. Source housing 910 and detectorhousing 915 curve about a separation 920. This produces a curve in abase 930. This allows the base to conform more easily to curvedsurfaces, such as the curved surface of a patient's skin.

FIG. 10 shows a cross-sectional view of the sensor. The sensor includesa sensor housing 1005 which in turn includes a detector housing 1008, asource housing 1011, and a base 1014. An adhesive film 1017 covers thebottom surface of the sensor housing base. A release liner 1020 with apull-tab 1021 covers the adhesive film.

Detector housing 1008 includes a cavity 1023. Cavity 1023 opens into acavity 1026 in the base. Cavity 1026 is coupled to opening 1030 on thebottom surface of the base which is partially covered by a lightdiffusing layer or semitranslucent film 1031. Cavities 1023 and 1026hold detectors 1033 a, 1033 b (not shown in this view), 1033 c, and 1033d (not shown in this view). An adhesive may be used to secure thedetectors in the cavity.

In a specific implementation with, for example, smaller detectorstructures, the detector structures may not extend into cavity 1023.Thus, cavity 1023 may only contain cable 1036. In anotherimplementation, the detector structures may have an even smaller profilesuch that they only occupy a portion of cavity 1026. In this case, cable1036 may also extend into cavity 1026 to connect with the detectorstructures.

Cables 1039 and 1042 (not shown in this view) enter into cavities in thesource housing. Cable 1039 enters into a cavity 1045 a in the sourcehousing. Cavity 1045 a opens into a cavity 1048 a in the base. Cavity1048 a is coupled to opening 1051 a. Cavities 1045 a and 1048 a holdsource structure 1054 a. An adhesive may be used to secure the sourcestructure in the cavities.

Though not shown in this view, a cable 1042 similarly enters cavities inthe source housing and base.

In a specific implementation, cables 1039 and 1042 travel along the topsurface of the source housing to approximately the midpoint of thesource housing before entering into their respective cavities. Thisprovides for a more secure connection of the cables to the sourcehousing. However, in other implementations, the cables will not travelalong the top surface of the source housing and will directly enter thecavity. In another implementation, the cables will travel along the topsurface of the sensor housing and enter the cavity before reaching themidpoint of the sensor housing. In yet another implementation, thecables will travel past the midpoint of the sensor housing beforeentering the cavity. In still another implementation, the cables willalso travel along the top surface of the detector housing.

In a specific implementation, the bottom surface of the detector andsource structures is in the same plane as the bottom surface of base. Inother implementations, the detector and source structures will extendpast the bottom surface of the base, release liner, or both. Thedetector and source structures may extend past the bottom surface of thebase from about 0.5 millimeters to about 1.5 millimeters. For example,the bottom surface of the detector and source structures may extendabout 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5 millimeters ormore past the bottom surface of the base. This helps to ensure, forexample, good contact of the detector and source structures to with thetissue.

In yet another implementation, the detector and source structures may berecessed into the bottom surface of the base. The detector and sourcestructures may be recessed from about 0.1 to 1.0 millimeters. Forexample, the bottom surface of the detector and source structures may berecessed about 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9 millimeters, ormore into the base.

In a specific implementation, the release liner covers the openings forthe detector and source structures. This helps to protect the detectorand source structures from debris. In other implementations, there maybe openings in the release liner that match the openings in the base forthe detector and source structures.

FIGS. 11a-11c show various placements of the sensor on the patient'sforehead.

FIG. 11a shows a first implementation of a sensor 1105 placed on a rightside 1108 of a patient's forehead 1111. The sensor includes an edge 1114and an inferior border 1117. In an implementation, the sensor is placedwith the inferior border approximately 1 centimeter above a patient'seyebrow 1120 and with edge 1114 approximately 1 centimeter away from amidline 1123 of the patient's forehead.

FIG. 11b shows a second implementation of a sensor 1126 placed on a leftside 1129 of the patient's forehead. In an implementation, a left-handside placement of the sensor is a mirror image of the right-hand sideplacement.

FIG. 11c shows a third implementation where sensors 1132 and 1135 areconcurrently placed on left and right sides of a patient's forehead. Ina specific implementation, each sensor calculates an oxygen saturationmeasurement independent of the other sensor. This allows, for example, abaseline measurement of one side to be made which can then be comparedwith a measurement of the other side.

In a specific implementation, the invention measures cerebral tissueoxygen saturation. This measurement can be used to assess oxygen supplyand blood circulation in the brain for the purpose of guiding cardiacsurgeries or other types of surgeries that would affect oxygen supplyand blood circulation in the brain. The different sensor placementsallow measurements to be taken at different regions of the brain.Different regions of the brain control may control different functions.Thus the measurements are useful in, for example, diagnosis andmonitoring. For example, the left side of the brain typically controlslanguage and speech skills. The right side of the brain typicallycontrols spatial perception and orientation.

FIG. 12 shows a process flow for using the sensor in accordance with anembodiment of the present invention. No threshold readings are requiredprior to taking a measurement.

In a step 1205, the user removes the sensor and its attached cables froma sterile package. In a step 1210, the user removes the release liner bygrasping the cable with one hand and pulling on the pull-tab with theother hand. This exposes the adhesive. In a specific implementation, amulti-piece release liner may be used in lieu of or in addition to apull-tab.

The user can place the sensor on the patient's left forehead, rightforehead, or both the left and right forehead. In a step 1215, the useraligns a long edge (i.e., inferior border from FIG. 11a ) of the sensorapproximately one centimeter above the patient's eyebrow. In a step1220, the user aligns a short edge of the sensor approximately onecentimeter away from the midline of the patient's forehead.

In a step 1225, the user presses the sensor onto the patient's forehead.This secures the sensor to the patient's skin. In a step 1230, the userthen attaches the cables to the monitoring console.

FIG. 13 is a schematic diagram of the sensor unit in use. The sensorunit includes source structures 1305 a and 1305 b which transmit lightinto a human head 1310 and detector structures 1315 a, 1315 b, 1315 c,1315 d which receive the transmitted light. Optical paths 1320, 1325 ofthe light generally follows the shape of a banana. The human head ismodeled as a medium with two layers—a shallow layer 1330 and a deeplayer 1335.

The shallow layer includes the scalp, skull, and cerebrospinal fluid.The attenuation coefficient for the shallow layer is μ₁. The thicknessd1 of the shallow layer is generally 12 millimeters.

The deep layer is the brain including gray matter and white matter. Theattenuation coefficient for the shallow layer is μ₂. The thickness d2 ofthe deep layer is considered infinite.

Table C below summarizes several optical properties of the adult head ata near infrared wavelength of 800 nanometers.

TABLE C Scattering Absorption Thickness Coefficient Coefficient TissueType (millimeters) μ′_(s) (1/millimeter) μ_(a) (1/millimeter) Scalp andskull 10 2.0 0.04 Cerebrospinal fluid 2 0.01 0.001 Gray matter 4 2.50.025 White matter ∞ 6.0 0.005

In an implementation having a symmetrical source and detectorarrangement as discussed in FIG. 7a , a distance between the source anddetectors is ρ. In an implementation having a nonsymmetrical orasymmetrical source and detector arrangement as discussed in FIG. 7b ,there may be two different distances between sources and detectors suchas ρ and ρ plus an offset distance that typically ranges from about 3 to5 millimeters.

This represents the separation between the position where light entersthe medium and the position where light exits from the medium. In animplementation, as described earlier, a near distance between the sourceand detectors is 30 millimeters. A far distance between the source anddetectors is 40 millimeters. Sources transmit light into the shallow anddeep layers. Detectors detect any resultant light that exits the shallowand deep layers.

In a specific implementation, a single pulse of light is transmittedinto the tissue. The light is then received by the near detectors (i.e.,1315 a and 1315 b) and far detectors (i.e., 1315 c and 1315 d). A firstattenuation value is then determined based on the light received by thenear detectors. This first attenuation value is used to calculate anattenuation coefficient for the shallow layer. The attenuationcoefficient of the deep layer is then calculated by using the shallowlayer attenuation coefficient and a second attenuation value based onlight received by the far detectors. The tissue oxygen saturation of thedeep layer is then calculated.

In another implementation, multiple pulses of light such as two pulsesof light are transmitted into the tissue. A first pulse of light may bereceived by the near detectors and a first attenuation value determined.A second pulse of light may be received by the far detectors and asecond attenuation value determined. The first attenuation value may beused to calculate an attenuation coefficient for the shallow layer. Theattenuation coefficient of the deep layer may then be calculated byusing the shallow layer attenuation coefficient and the secondattenuation value. The tissue oxygen saturation of the deep layer maythen be calculated.

A Monte Carlo simulation can be used to describe the photon propagation.For example, let Γ(ρ) be the light intensity profile, where β(ρ) δρ canbe interpreted as the probability that a photon exits the surface at adistance between ρ and ρ+δρ. The intensity profile can be represented bythe following equation:

$\begin{matrix}{{{{\Gamma(\rho)} \approx {\frac{1}{4\;\pi\;\rho^{2}}\left\lbrack {{\sqrt{6\;\mu_{1}}{\mathbb{e}}^{{- \rho}\sqrt{6\;\mu_{1}}}} + {\sqrt{6\;\mu_{2}}{\mathbb{e}}^{{{- \rho}\sqrt{6\;\mu_{2}}} - {m{({\mu_{1} - \mu_{2}})}}}}} \right\rbrack}},{\mu_{1} > \mu_{2}}}\mspace{20mu}{{{where}\mspace{14mu} m} = {\frac{5.2\; d\; 1}{\sqrt{\mu_{1}}}.}}} & (1)\end{matrix}$According to table C, d1=1.2 centimeters, i.e., 12 millimeters.

For the shallow layer, μ₁=μ₂

${\Gamma(\rho)} \approx {\frac{1}{2\;\pi\;\rho^{2}}\sqrt{6\;\mu_{1}}{\mathbb{e}}^{{- \rho}\sqrt{6\;\mu_{1}}}}$

In the auto-calibration scheme,

${\Gamma^{(4)} \approx {\left( \frac{\rho_{12}\rho_{21}}{\rho_{11}\rho_{22}} \right)^{2}{\mathbb{e}}^{{- {({\rho_{11} - \rho_{12} + \rho_{22} - \rho_{21}})}}\sqrt{6\;\mu_{1}}}}},$

Therefore,

$\begin{matrix}{\mu_{1} = {\frac{1}{6}\left\lbrack \frac{{2\;\ln\;\frac{\rho_{12}\rho_{21}}{\rho_{11}\rho_{22}}} - {\ln\;\Gamma^{(4)}}}{\rho_{11} - \rho_{12} + \rho_{22} - \rho_{21}} \right\rbrack}^{2}} & (2)\end{matrix}$

The attenuation coefficient for deep layer μ₂ is then determined usingequation 1 using the attenuation coefficient for the shallow layer μ₁calculated from equation 2.

The generalized governing equation for describing migration of photonsor propagation of electromagnetic waves in a medium is given by:I=α·β·γ·I _(o) ·e ^((−β·L·δ·Σ) ^(i) ^((ε) ^(i) ^(C) ^(i) ^()+σ))  (3)

It is appreciated that the system parameters “γ” and “δ” may have thevalue of 1.0 and “σ” may be 0.0. One simplified version of equation 3may be obtained when the parameters “γ” and “δ” are approximated as aunity:I=α·β·I _(o) ·e ^((−β·L·Σ) ^(i) ^((εi·Ci)+σ))  (4)

The convention “photon diffusion equation” has the same form as equation4:I=S·D·I _(o) ·e ^((−β·L·Σ) ^(i) ^((εi·Ci)+A))  (5)

where “S” corresponds to “α” of equation 4 and generally accounts forcharacteristics of the wave source such as power and configurationthereof, mode of optical coupling between the wave source and medium, oroptical coupling loss therebetween, and combinations of these, “D”corresponds to “β” of equation 4 and generally accounts forcharacteristics of the wave detector, mode of optical coupling betweenthe wave detector and medium, or the associated coupling loss, andcombinations of these, and “A” corresponds to “δ” of equation 4 whichmay be either a proportionality constant or a parameter associated withthe wave source, wave detector, or medium, and combinations of these.

For illustration purposes, an exemplary optical system may include,e.g., two wave sources (S1 and S2) each emitting electromagnetic wavesof wavelength λ₁ and two wave detectors (D1 and D2) arranged to detectat least a portion of such electromagnetic waves. Applying the photondiffusion equation 5 to each pair of the wave sources and detectors ofthe exemplary optical system yields the following set of equations:

$\begin{matrix}{I_{S\; 1D\; 1}^{\lambda\; 1} = {I_{S\; 1}^{\lambda\; 1} \cdot S_{1} \cdot D_{1} \cdot {\mathbb{e}}^{{{- {B_{S\; 1D\; 1}{({\sum\limits_{i}{ɛ_{i}^{\lambda_{1}}C_{i}}})}}}L_{S\; 1D\; 1}} + A}}} & (6) \\{I_{S\; 1D\; 2}^{\lambda\; 1} = {I_{S\; 1}^{\lambda\; 1} \cdot S_{1} \cdot D_{2} \cdot {\mathbb{e}}^{{{- {B_{S\; 1D\; 2}{({\sum\limits_{i}{ɛ_{i}^{\lambda_{1}}C_{i}}})}}}L_{S\; 1D\; 2}} + A}}} & (7) \\{I_{S\; 2D\; 1}^{\lambda\; 1} = {I_{S\; 2}^{\lambda\; 1} \cdot S_{2} \cdot D_{1} \cdot {\mathbb{e}}^{{{- {B_{S\; 2D\; 1}{({\sum\limits_{i}{ɛ_{i}^{\lambda_{1}}C_{i}}})}}}L_{S\; 2D\; 1}} + A}}} & (8) \\{I_{S\; 2D\; 2}^{\lambda\; 1} = {I_{S\; 2}^{\lambda\; 1} \cdot S_{2} \cdot D_{2} \cdot {\mathbb{e}}^{{{- {B_{S\; 2D\; 2}{({\sum\limits_{i}{ɛ_{i}^{\lambda_{1}}C_{i}}})}}}L_{S\; 2D\; 2}} + A}}} & (9)\end{matrix}$

where the superscript λ₁ denotes that various variables and parametersare obtained at the wavelength of λ₁.

A mathematical operation may eliminate at least one system parameterfrom the equations 6 to 9. For example, the source coupling factors suchas S₁ and S₂ may be canceled therefrom by taking the first ratio of theequation 6 to 7 and by taking the fourth ratio of the equation 8 to 9.Logarithms of the first and second ratios are then taken to yield whatare conventionally termed as “optical densities” (i.e., OD₁ ^(λ) ¹ isdefined as a logarithm of I_(S1D1) ^(λ) ¹ /I_(S1D2) ^(λ) ¹ and OD₂ ^(λ)² defined as a logarithm of I_(S2D2) ^(λ) ¹ /I_(S2D1) ^(λ) ¹ ). It isnoted that these optical densities are generally insensitive to exactmodes of optical coupling between the wave source and the physiologicalmedium:

$\begin{matrix}{{OD}_{1}^{\lambda_{1}} = {{\ln\;\frac{I_{S\; 1D\; 1}^{\lambda_{1}}}{I_{S\; 1D\; 2}^{\lambda_{1}}}} = {{\ln\;\frac{D_{1}}{D_{2}}} + {\left( {{B_{S\; 1D\; 2}^{\lambda_{1}}L_{S\; 1D\; 2}} - {B_{S\; 1D\; 1}^{\lambda_{1}}L_{S\; 1\; D\; 1}}} \right){\sum\limits_{i}{ɛ_{i}^{\lambda_{1}}C_{i}}}}}}} & (10) \\{{OD}_{2}^{\lambda_{1}} = {{\ln\;\frac{I_{S\; 2D\; 2}^{\lambda_{1}}}{I_{S\; 2D\; 1}^{\lambda_{1}}}} = {{\ln\;\frac{D_{2}}{D_{1}}} + {\left( {{B_{S\; 2D\; 1}^{\lambda_{1}}L_{S\; 2D\; 1}} - {B_{S\; 2D\; 2}^{\lambda_{1}}L_{S\; 2\; D\; 2}}} \right){\sum\limits_{i}{ɛ_{i}^{\lambda_{1}}C_{i}}}}}}} & (11) \\{\mspace{20mu}{{OD}^{\lambda_{1}} = {{OD}_{1}^{\lambda_{1}} + {OD}_{2}^{\lambda_{1}}}}} & (12)\end{matrix}$

The cerebral tissue oxygen saturation can then be calculated using, inpart, equations 10 and 11, or equation 12, i.e., an automatic errorcancellation scheme. These equations are discussed in more detail asequations 5a and 5b in U.S. Pat. No. 6,597,931, which is incorporated byreference.

This description of the invention has been presented for the purposes ofillustration and description. It is not intended to be exhaustive or tolimit the invention to the precise form described, and manymodifications and variations are possible in light of the teachingabove. The embodiments were chosen and described in order to bestexplain the principles of the invention and its practical applications.This description will enable others skilled in the art to best utilizeand practice the invention in various embodiments and with variousmodifications as are suited to a particular use. The scope of theinvention is defined by the following claims.

The invention claimed is:
 1. A method comprising: positioning a sensor head of a tissue oximeter to face toward a tissue, wherein the tissue oximeter can measure oxygen saturation of the tissue without requiring a pulse, the sensor head comprises a first source structure, a second source structure, a far detector arrangement, a near detector arrangement, and a semitranslucent film covering the near detector arrangement; transmitting light through the first source structure and the second source structure into a tissue; receiving a first light transmitted through the tissue and the semitranslucent film covering the near detector arrangement at the near detector arrangement, the first received light at the near detector arrangement including attenuation characteristics due to the semitranslucent film; receiving a second light transmitted through the tissue at the far detector arrangement, the second received light not passing through the semitranslucent film, and the second received light at the far detector arrangement not including the attenuation characteristics; and processing the first and second received light using a system unit.
 2. The method of claim 1 wherein the transmitting light through the first source structure and the second source structure into a tissue, is from the system unit.
 3. The method of claim 1 wherein the attenuation characteristics are at least partially caused by the semitranslucent film.
 4. A method comprising: placing a sensor head on a surface of a tissue to be measured; transmitting light through a plurality of sources of the sensor head into the tissue; receiving light transmitted through the tissue at a first detector structure and a second detector structure of a first plurality of detectors and at a third detector structure and a fourth detector structure of a second plurality of detectors, wherein the first detector structure detects a first attenuated amount of light, and the third detector structure detects a second attenuated amount of light; using the first attenuated amount, calculating a first attenuation coefficient for a shallow tissue region having a depth of at most about X below the surface of the tissue; and using the second attenuated amount and the first attenuation coefficient, calculating a second attenuation coefficient for a deep tissue region having a depth of at least about Y below the surface of the tissue.
 5. The method of claim 4 wherein X is equal to Y.
 6. The method of claim 4 wherein X is different from Y.
 7. The method of claim 4 wherein X is less than Y.
 8. The method of claim 4 wherein X and Y are about 12 millimeters.
 9. The method of claim 4 wherein the tissue comprises a human scalp, skull, and brain.
 10. The method of claim 4 wherein the second attenuated amount is not used in calculating the first attenuation coefficient.
 11. The method of claim 4 wherein the calculating the second attenuation coefficient is performed after calculating the first attenuation coefficient.
 12. The method of claim 4 wherein the second attenuated amount is greater than the first attenuated amount.
 13. The method of claim 4 wherein a near distance from the plurality of sources to the first plurality of detectors is less than a far distance from the plurality of sources to the second plurality of detectors.
 14. The method of claim 4 wherein the plurality of sources comprises a first source structure and a second source structure, wherein the first source structure, second source structure, first detector structure, and second detector structure define vertices of a quadrilateral, and a first side of the quadrilateral between the first source structure and first detector structure is same in length from a second side of the quadrilateral between the second source structure and the second detector structure.
 15. The method of claim 4 wherein the plurality of sources comprises a first source structure and a second source structure, wherein the first source structure, second source structure, first detector structure, and second detector structure define vertices of a quadrilateral, and a first side of the quadrilateral between the first source structure and first detector structure is different in length from a second side of the quadrilateral between the second source structure and the second detector structure.
 16. The method of claim 4 wherein the sensor head comprises a tissue oximeter that can measure oxygen saturation without requiring a pulse.
 17. The method of claim 4 wherein the tissue to be measured comprises no blood flow.
 18. The method of claim 1 wherein the tissue to be measured comprises no blood flow.
 19. The method of claim 4 wherein the calculating a first attenuation coefficient is completed without using the second attenuation coefficient.
 20. The method of claim 4 wherein the detectors and the sources protrude out from a bottom surface of a base of the sensor head.
 21. The method of claim 4 wherein the sensor head comprises a first portion and a second portion, a base is coupled to the first and second portions, the sources are housed in the first portion, the first and second detectors are housed in the second portion, there is a separation between the first portion and second portion of the sensor head, the base does not have the separation, and the base is adapted to contact the surface of a tissue to be measured, whereby the separation allows the sensor head to more easily conform to a curved surface.
 22. The method of claim 4 wherein a bottom surface of a base of the sensor head comprises an adhesive.
 23. The method of claim 21 wherein a bottom surface of the base of the sensor head comprises an adhesive, the first and second portions comprise a foam, and a thickness of the foam of the first and second portions is greater than a thickness of the base.
 24. The method of claim 21 wherein a first set of cables are coupled to the source through a back of the first portion of sensor head, and a second set of cables are coupled to the detectors through a side edge of the second portion of sensor head.
 25. The method of claim 14 wherein a third side of the quadrilateral between the first source structure and the second source structure is parallel to a fourth edge of the quadrilateral between the first detector structure and the second detector structure.
 26. The method of claim 14 wherein the first detector structure, second detector structure, third detector structure, and fourth detector structure define vertices of a quadrilateral, and a first side of the quadrilateral between the first detector structure and third detector structure is same in length from a second side of the quadrilateral between the second detector structure and the fourth detector structure.
 27. The method of claim 4 wherein an arrangement of the sources comprises a first source comprising a first distance to a first detector of the first detectors, a second source comprising a second distance to a second detector of the first detectors, and the first distance is about equal to the second distance.
 28. The method of claim 4 comprising: covering the first plurality of detectors with a light diffusing layer while not covering the second plurality of detectors with this light diffusing layer.
 29. A method comprising: positioning a sensor head to face toward a tissue, wherein the sensor head comprises a first source structure, a second source structure, a far detector arrangement, a near detector arrangement, and a semitranslucent film covering the near detector arrangement; transmitting light through the first source structure and the second source structure into a tissue; receiving a first light transmitted through the tissue and the semitranslucent film covering the near detector arrangement at the near detector arrangement, the first received light at the near detector arrangement including attenuation characteristics due to the semitranslucent film; receiving a second light transmitted through the tissue at the far detector arrangement, the second received light not passing through the semitranslucent film, and the second received light at the far detector arrangement not including the attenuation characteristics; and processing the first and second received light using a system unit, wherein the sensor head comprises a first portion and a second portion, a base is coupled to the first and second portions, the sources are housed in the first portion, the first and second detectors are housed in the second portion, there is a separation between the first portion and second portion of the sensor head, the base does not have the separation, and the base is adapted to contact the surface of a tissue to be measured, and the first and second portions comprise a foam, a thickness of the foam of the first and second portions is greater than a thickness of the base, and the bottom surface of the base of the sensor head comprises an adhesive.
 30. The method of claim 29 wherein the near detector arrangement comprises a first detector structure and a second detector structure, wherein the first source structure, second source structure, first detector structure, and second detector structure define vertices of a quadrilateral, and a first side of the quadrilateral between the first source structure and first detector structure is same in length from a second side of the quadrilateral between the second source structure and the second detector structure.
 31. The method of claim 29 wherein the near detector arrangement comprises a first detector structure and a second detector structure, wherein the first source structure, second source structure, first detector structure, and second detector structure define vertices of a quadrilateral, and a first side of the quadrilateral between the first source structure and first detector structure is different in length from a second side of the quadrilateral between the second source structure and the second detector structure.
 32. A method comprising: positioning a sensor head of a tissue oximeter to face toward a tissue, wherein the tissue oximeter can measure oxygen saturation of the tissue without requiring a pulse, the sensor head comprises a first source structure, a second source structure, a first plurality of detectors comprising a first detector and second detector, a second plurality of detectors comprising the third detector and fourth detector, and a semitranslucent film covering the first plurality of detectors; transmitting light through the first source structure and the second source structure into the tissue; receiving a first light transmitted through the tissue and the semitranslucent film covering the first plurality of detectors at the first plurality of detectors, the first received light at the first plurality of detectors including attenuation characteristics due to the semitranslucent film; receiving a second light transmitted through the tissue at the second plurality of detectors, the second received light not passing through the semitranslucent film, and the second received light at the second plurality of detectors not including the attenuation characteristics; and processing the first and second received light using a system unit of the tissue oximeter, wherein the first detector is positioned closer to the first source structure than the third detector, and the second detector is positioned closer to the second source structure than the fourth detector, the first and second source structures form a first line, the first and second detectors form a second line, and between the first and second detectors, the second line does not intersect with the first line, and the third and fourth detectors form a third line, and the third line is different from the second line.
 33. The method of claim 32 wherein a first distance between the first source structure and the first detector is the same as a second distance between the second source structure and the second detector.
 34. The method of claim 32 wherein a first distance between the first source structure and the first detector is different from a second distance between the second source structure and the second detector.
 35. The method of claim 32 further comprising: using the first received light, calculating a first attenuation coefficient for a shallow tissue region having a depth of at most about X below the surface of the tissue, wherein the shallow tissue region comprises a three-dimensional region, and at a depth of X, this region extends in directions parallel and transverse to the second line; using the second received light and the first attenuation coefficient, calculating a second attenuation coefficient for a deep tissue region having a depth of at least about Y below the surface of the tissue, wherein the deep tissue region comprises a three-dimensional region, and at a depth of Y, this region extends in directions parallel and transverse to the third line; and using the second attenuation coefficient for the deep tissue region, calculating an oxygen saturation measurement for the deep tissue region.
 36. The method of claim 29 wherein the first portion comprises a first edge, the second portion comprises a second edge, and without the first and second portions being decoupled from the base, for a first sensor head positioning, the first edge can be positioned to touch the second edge, and for a second sensor head positioning, the first edge can be positioned relative to the second edge to have a separation distance of at least 0.5 millimeters. 